Quality Assurance Specialist

Meds; Elmhurst (IL); Vor Ort; USD 70.000 - 80.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision coverage

Short-Term Disability

Life Insurance

401(k) with company match

Complimentary daily lunch on-site

Zusammenfassung

Meds.com, Elmhurst, IL, is seeking a meticulous Quality Assurance Specialist to ensure product safety, regulatory compliance, and operational quality in our pharmacy operations. You will audit processes, review batch records, and ensure SOP adherence on the pharmacy floor, collaborating with the QA team and operations.

The role requires a bachelor’s in a scientific field and 2+ years in QA/regulatory roles within pharma.

Qualifikationen

• Bachelor’s degree in Chemistry, Biology, Pharmacy Science, or a related scientific field is strongly preferred.
• 2+ years of experience in quality assurance, quality control, or regulatory compliance within a pharmacy, pharmaceutical manufacturing, or cGMP-regulated environment.
• Familiarity with pharmacy compounding regulations (USP 795/797/800) and state board standards.
• Exceptional precision and thoroughness when inspecting products, reviewing batch records, and maintaining documentation.
• Strong written and verbal communication skills with the ability to clearly document technical findings and collaborate with pharmacy staff.

Aufgaben

• Serves as primacy quality records coordinator and QA Manager with broader quality assurance initiatives.
• Support Quality lead on announced and unannounced inspections.
• Support 5S goals to create a better organized, safer, cleaner, and more efficient workplace.
• Support development, review, and updating of pharmacy policies, procedures, logs/forms, and training materials.
• Maintain knowledge of current regulatory requirements pertaining to USP non-sterile compounding.
• Manage SOPs and Forms Control index.
• Coordinate monthly QA meetings and related items under the Director of Quality Assurance.
• Onboard new hires and initiate training; manage training through quizzes and updates.
• Maintain training logs for team members and coordinate annual training.

Kenntnisse

Quality assurance

Documentation

Regulatory compliance

Attention to detail

Ausbildung

Bachelor's degree in Chemistry, Biology, Pharmacy Science, or related field

Jobbeschreibung

Meds.com is a rapidly growing consumer technology firm operating a suite of healthcare businesses, including our flagship brands BlueChew and MOD. Our mission is to better patients' lives through innovative healthcare solutions. With a team of over 500 professionals across various specialties, we've built scalable pharmacy, telemedicine, and e-commerce platforms using cutting-edge technology. As we continue our accelerated growth trajectory, we're launching new products to expand our patient base and accelerate growth. Join us in tackling exciting challenges at the intersection of healthcare and technology.

We’relooking for a meticulous, quality-focusedQuality Assurance Specialistto join our team at our Elmhurst pharmacy facility. In this role, you will play a critical part inmaintainingthe highest standards of product safety, regulatory compliance, and operational quality across our daily compounding and fulfillment processes.

Working directly on the pharmacy floor, you will collaborate closely with pharmacy operations and the broader QA team to audit processes, perform batch record reviews, inspect incoming materials, and ensure full adherence to standard operating procedures (SOPs) and state/federal regulations. If you thrive in a fast-paced environment and have a keen eye for detail, you will help us ensure every patient receives safe, top-quality care.

Join our team in Elmhurst, IL -we'relooking for someone who truly values and enjoys working onsite, not just tolerates it.

Responsibilities

• Serves as primacy quality records coordinator and QA Manager with broader quality assurance initiatives.
• Support Quality lead on announced and unannounced inspections
• Support 5S goals to create andmaintaina better organized, safer, cleaner, and more efficient workplace.
• Support the development, review, and updating ofpharmacy policies, procedures, logs/forms, and training materials.
• Maintain a strong knowledge base in current regulatory requirementspertaining toUSP non-sterile compounding.
• Manage SOPs and Forms Control index.
• Ensure policies and procedures are compliant with current regulatory, health, and safety standards.
• Coordinate monthly QA meetings and related items as requested under the direction of the Director of Quality assurance.
• Supports onboarding new hires byinitiatingtraining.
• Support the management of training through quizzes andupdateas needed when policies or procedures are developed.
• Manage andretaintraining logs for team members that are assigned training as completed.
• Assistin coordinating annual training.‘
• Responsible formaintainingrecords of all pharmacy activities including but not limited to:
• Collection and review of BPRs
• Document dailymonitorof temperature and humidity for pharmacy on a monthly/quarterlybasis.
• Manage filing of SDS, equipment list, CAPAs, cleaning logs, and otherdocumentsrecord retention.
• Develop andmaintainmonthly logbookspertaining toQA and Operations (e.g., Cleaning Checklists and Waste Logs).
• Provide support in the collection and documenting data trends.
• In collaboration withoperationsmaintainequipment calibration records and monitor schedules.
• Monitor and document Monitor FDA weekly enforcement logon a monthly basisfor any recalls that couldimpactraw ingredients or materials received.
• Reviews all Certificate of Analysis of products provided by contract manufacturers, which need to be documented andproperly stored.
• Retain any waste disposal documentationassociated.
• Assistsinmaintaininga safe work environment byassistingin safety programs, and by conducting safety audits (Hazards Training Program, Spill Kits, Eye Wash)
• Assistin conducting and documenting annual drills and staff demonstrations in hazardous trainingprogram.
• Conduct and document monthly RO pH testing.
• Coordinateand document monthly RO filter checks and cleaning.
• Coordinate processes to ensure that any rejected product is quarantined and removed from the receiving/affected location.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy Science, or a related scientific field is strongly preferred.
• 2+ years of experience in quality assurance, quality control, or regulatory compliance within a pharmacy, pharmaceutical manufacturing, or cGMP-regulated environment.
• Familiarity with pharmacy compounding regulations (e.g., USP <795>, <797>, or <800> guidelines) and state board of pharmacy standards.
• Exceptional precision and thoroughness when inspecting products, reviewing batch records, andmaintainingdocumentation.
• Strong written and verbal communication skills with the ability to clearly document technical findings and collaborate effectively with pharmacy technicians and management.
• 100% company-paid Medical, Dental, and Vision premium coverage for employees, plus.
• Short-Term Disability and Life Insurance
• 401(k) with company match
• Complimentary daily lunch provided on-site

Salary Range: $70,000.00 - $80,000.00 annually

We are looking fortop-talentthat wants to make a measurable impact in an exciting, fast-paced environment. This role is full-time in Elmhurst, IL.